MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 CAPSURE; STAPLE, IMPLANTABLE

Catalog Number 0113215

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/19/2024

Event Type  malfunction  

Event Description

As reported, when the capsure device was used to fixate the mesh, the first fastener head fell off when the shaft was pulled.It was reported that the head was recovered, and the coil part was carefully checked around the mesh but could not be found.It was also reported that the first shot may not have the coil part originally attached.It was reported that from second shot the fasteners were able to fix without any problems, but surgeon memory is vague as to whether it was the same device or a replacement, the details are currently being investigated in the operating theatre.There was no reported patient injury.

Manufacturer Narrative

As reported, the capsure device's first fastener's head detached from coil and recovered; the coil may be left in patient.Visual evaluation of the fastener peek cap found that the head had become detached from the coil as a result of the coil wire failing just under the head of the fastener.The most likely cause of this fastener failure is the fastener being driven into a hard structure such as bone and the device torque being high enough to cause failure of the coil wire under the head.In that case the coil would be embedded in tissue and would not be visible to the surgeon.The instructions-for-use (ifu) supplied with the device adequately describe the proper technique for fastener delivery.The ifu states: "care should be taken not to use excessive counter pressure as this may damage the tissue, the material being fixated, and/or the device" and "carefully inspect the area in the vicinity of the tissue being fastened to avoid inadvertent penetration of underlying structures such as bone, nerves, vessels, and viscera.Use of the capsure permanent fixation system in the close vicinity of such underlying structures is contraindicated." review of manufacturing records confirms product was manufactured to specification, with no indication of a manufacturing related cause for the event reported.This event remains the only complaint to be reported to date, for this manufacturing lot of 780 units released for distribution in (b)(6) 2023.Note: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.Sample evaluated.

• Brand Name: CAPSURE
• Type of Device: STAPLE, IMPLANTABLE
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC. -1213643; 100 crossings blvd.; warwick RI 02886
• Manufacturer (Section G): BARD SHANNON LIMITED -3005636544; san geronimo industrial park; lot #1, road #3, km 79.7; humacao PR 00791
• Manufacturer Contact: andrew topoulos ; 100 crossings blvd.; warwick, RI 02886 ; 8005566756
• MDR Report Key: 18921778
• MDR Text Key: 337874469
• Report Number: 1213643-2024-00094
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 00801741094989
• UDI-Public: (01)00801741094989
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K142808
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0113215
• Device Lot Number: HUHS0997
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2024
• Date Manufacturer Received: 02/20/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/25/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other